Phase I Trial, Quotient Code: QSC205947
| ISRCTN | ISRCTN97798065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97798065 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1006953 |
| Protocol serial number | IRAS 1006953, Quotient Code: QSC205947 |
| Sponsor | Ventyx Biosciences, Inc. |
| Funder | Ventyx Biosciences, Inc. |
- Submission date
- 17/02/2023
- Registration date
- 23/02/2023
- Last edited
- 05/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Principal investigator
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 3031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public
662 Encinitas Blvd, Suite 250
Encinitas
CA 92024
United States of America
| Phone | +1 888 411 5176 |
|---|---|
| ClinicalTrials@ventyxbio.com |
Scientific
662 Encinitas Blvd, Suite 250
Encinitas
CA 92024
United States of America
| Phone | +1 888 411 5176 |
|---|---|
| ClinicalTrials@ventyxbio.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pharmacokinetics trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase I Trial, Quotient Code: QSC205947 [The full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) | 1. Approved 03/04/2023, Wales REC 2 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2071048222, +44 (0)2920230457, +44 (0)7920 565664; Wales.REC2@wales.nhs.uk); ref: 23/WA/0014. 2. Approved 03/04/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 57619/0001/001-0001 The HRA has approved deferral of publication of trial details. |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Primary outcome measure(s) |
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key secondary outcome measure(s) |
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Completion date | 17/11/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 20 |
| Key inclusion criteria | Healthy human volunteer |
| Key exclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 04/04/2023 |
| Date of final enrolment | 17/11/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/12/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 28/07/2023 to 17/11/2023.
2. The overall study end date was changed from 28/07/2023 to 17/11/2023.
3. The intention to publish date was changed from 28/01/2026 to 17/05/2026.
05/04/2023: The HRA has confirmed that it has approved deferral.
05/04/2023: The ethics approval was added.
23/02/2023: Trial's existence confirmed by MHRA.
